October 15, 2020
Otsuka Pharmaceutical Co., Ltd.
Otsuka and its subsidiary Astex announce results of phase 3, ASTRAL-2 and ASTRAL-3 trials of guadecitabine in patients with previously treated AML and MDS/CMML
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and its California-based subsidiary Astex Pharmaceuticals, Inc. (Astex) announce top-line results of the ASTRAL-2 and ASTRAL-3 clinical trials that evaluated the efficacy and safety of guadecitabine (SGI-110) in adults with previously treated AML (acute myeloid leukemia), and in adults with previously treated MDS or CMML (myelodysplastic syndromes / chronic myelomonocytic leukemia), respectively.
Neither the ASTRAL-2 trial in patients with AML nor the ASTRAL-3 trial in patients with MDS or CMML met the primary endpoint of statistically significant (p <0.05) improvement in overall survival (OS) compared with the control arm of physicians' choice of alternative therapy. Evaluation of the studies' prospective subgroups, and secondary endpoints is ongoing. Safety data were consistent with the expected safety profile of guadecitabine from prior studies. The full data will be presented at upcoming scientific meetings.
Otsuka and Astex and Otsuka announced in July 2018 that the phase 3 ASTRAL-1 randomized trial of guadecitabine in adults with previously untreated AML who were not eligible for intensive induction chemotherapy (https://www.clinicaltrials.gov NCT02348489) failed to meet its co-primary endpoints.
Guadecitabine is also being evaluated in over twenty investigator-sponsored trials in other hematological malignancies and in solid tumors, both as a single agent, and in combination with chemotherapy or immunotherapy.
Guadecitabine, a DNA hypomethylating agent, is an investigational compound and is not currently approved in any country.
Information in this news release was current as of the original release date.